Healthy
Conditions
Brief summary
A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects. The primary objectives are to address the following questions: To evaluate the impact of high-fat and low-fat meals on the pharmacokinetic (PK) characteristics of a single oral dose of FWD1802 in healthy Chinese Subjects.
Detailed description
A Phase I, single-center, open-label, randomized, single-dose, three-period crossover study conducted in Chinese healthy subjects to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of FWD1802. A total of 18 healthy subjects are planned to be enrolled. Subjects will be randomly assigned in a 1:1:1 ratio to one of three sequences. Each sequence consists of three cycles, with one dose administered per cycle, and a washout period of ≥14 days between consecutive doses. The three sequences are as follows: Sequence 1: Cycle 1 - administration under fasting conditions; Cycle 2 - administration after a low-fat meal; Cycle 3 - administration after a high-fat meal. Sequence 2: Cycle 1 - administration after a low-fat meal; Cycle 2 - administration after a high-fat meal; Cycle 3 - administration under fasting conditions. Sequence 3: Cycle1 - administration after a high-fat meal; Cycle 2 - administration under fasting conditions; Cycle 3 - administration after a low-fat meal. Notes: 1. Fasting Condition (Reference): A single dose of 150 mg FWD1802 is taken orally after fasting for at least 10 hours (water is allowed as needed). 2. Low-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a low-fat meal. 3. High-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a high-fat meal. 4. Low-Fat Meal: Total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content. 5. High-Fat Meal: A high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), with approximately 150, 250, and 500-600 Kcal derived from protein, carbohydrates, and fat, respectively. The composition of the high-fat and low-fat meals must be consistent across all cycles.
Interventions
DRUGFWD1802
Single-dose of 150 mg of FWD1802.
Sponsors
Forward Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1. The subject understands the trial's objectives, nature, methods, and potential adverse reactions, voluntarily participates, and signs the informed consent form, ensuring that all trial procedures will be personally undertaken by the subject. 2. Chinese male or female subjects, aged 18-45 years (inclusive) for males and 18-50 years (inclusive) for females at the time of screening. 3. Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females. 4. Results from screening assessments, including medical history inquiry, vital signs \[body temperature (tympanic), pulse, blood pressure (seated)\], comprehensive physical examination, laboratory tests (complete blood count, blood chemistry, urinalysis, coagulation function), 12-lead electrocardiogram (ECG), abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), and chest X-ray (posteroanterior view), are all within normal limits or show abnormalities that are not clinically significant. 5. Female subjects have no pregnancy plan and voluntarily agree to use effective contraceptive measures (Appendix 1) from 2 weeks prior to the first dose until 6 months after the last dose / Male subjects have no pregnancy plan for their partners and voluntarily agree to use effective contraceptive measures (Appendix 1) from the first dose until 6 months after the last dose, with no plans for sperm or egg donation.
Exclusion criteria
* Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 240 hours | Peak Plasma Concentration (Cmax) of FWD1802 |
| Area under the plasma concentration versus time curve (AUC0-t) | 240 hours | Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point of FWD1802 |
| Area under the plasma concentration versus time curve (AUC0-∞) | 240 hours | Area under the plasma concentration versus time curve from time zero extrapolated to infinity of FWD1802 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Peak Concentration (Tmax) | 240 hours | Time to Peak Concentration (Tmax) of FWD1802 |
| Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity | 240 hours | Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity of FWD1802 |
| Absorption lag time (t lag) | 240 hours | Absorption lag time (t lag) of FWD1802 |
| Half-life (t₁/₂) | 240 hours | Half-life (t₁/₂) of FWD1802 |
| Apparent clearance (CL/F) | 240 hours | Apparent clearance (CL/F) of FWD1802 |
| Apparent volume of distribution (Vz/F) | 240 hours | Apparent volume of distribution (Vz/F) of FWD1802 |
| Elimination rate constant (Kel) | 240 hours | Elimination rate constant (Kel) of FWD1802 |
| Mean residence time (MRT) | 240 hours | Mean residence time (MRT) of FWD1802 |
| Inter-individual variability | 240 hours | Interindividual variability in the primary PK parameters AUC₀-ₜ, AUC₀-∞, and Cmax following administration of FWD1802 |
| Intraindividual variability | 240 hours | Intraindividual variability in the primary PK parameters AUC₀-ₜ, AUC₀-∞, and Cmax of FWD1802 |
| Monitoring and Recording of AE and Laboratory Tests in Subjects. | 240 hours | Number of Participants with Adverse Events (AEs), Abnormal Safety Laboratory Findings, Abnormal Vital Signs, and Abnormal 12-Lead Electrocardiogram (ECG) Results |
Countries
China
Contacts
CONTACTLimin Yin
PRINCIPAL_INVESTIGATORYanmei Liu
Shanghai Xuhui Central Hospital
Outcome results
None listed